Infertility Assisted Reproductive TechnologyNCT07533630
Prospective International Multi-center Clinical Trial of PGT-A Upgrade
An observational study of Infertility Assisted Reproductive Technology, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 7 sites in 5 countries.
Trial summary
The goals of this international multicenter cross-sectional study are: 1. To provide patients with a comprehensive PGT solution capable of simultaneously detecting embryonic chromosomal aneuploidy, mosaicism, microdeletions/ microduplications, heteroploidy, and heterozygosity (LOH) in a single assay, thereby reducing… Read more about this study
- Who is it for?
- Ages 20 to 46 years, women only
- Conditions the study is for
- Infertility Assisted Reproductive Technology
- What is being tested?
- PGT-A upgrade
- How many people
- 1,700 participants
- Where
- 7 sitesin 5 countries
- Study dates
- May 2026to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 46 years
- Women only
- No healthy volunteers
- Adult
Study population: This study is a cross-sectional study with a two-sided test and α = 0.05. Based on the analysis of existing data from previous PGT-A upgrade studies performed in 2PN embryos, the total incidence rate (p) of microdeletion/microduplication, heteroploidy, and UPD/LOH in euploid embryos is estimated to be 2.0%, with a margin of error (δ) of 0.005. The required number of euploid embryos is 3,012, and the calculation formula is provided below. Given that the euploidy rate is approximately 50%, a total of 6,024 embryos tested by PGT-A upgrade needs to be enrolled. Considering the potential dropout risk (10%), 6,694 embryos from two pronuclei (PN) are included. All embryos from 0PN/1PN/3PN are included.
Who may be able to join
- Any one of the following conditions being met is sufficient:
- advanced maternal age (AMA, age ≥35 years),
- recurrent implantation failure (RIF),
- recurrent miscarriage (RM),
- severe male factor (SMF). (2) And at least one blastocyst is available.
Who cannot join
- Couples undergoing PGT-SR due to chromosomal structural abnormalities carried by either one or both members, such as balanced translocations, Robertsonian translocations, inversions, complex chromosomal rearrangements, and pathogenic microdeletions or microduplications;
- Couples undergoing PGT-M;
- Conditions with established impact on uterine morphology or endometrial receptivity, including untreated uterine malformations (septate uterus, unicornuate uterus, didelphic uterus, etc.) and untreated hydrosalpinx;
- Embryos coming from oocyte or sperm (gametes) donation;
- Individuals with contraindications to pregnancy or assisted reproduction technology.
Trial locations and contacts
7 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 5 countries
China3 sites
CITIC-Xiangya Reproductive & Genetic Hospital
Changsha, Hunan
Pingyuan Xie, 8613755122491, plainxie192@126.com
Ge Lin
First People's Hospital of Yunnan Province
Kunming, Yunnan
Yunxiu Li, 8613888100779, 105935559@qq.com
Yunxiu Li
Nanjing Women and Children's Healthcare Hospital
Nanjing, Jiangsu
Xiufeng Ling, 8613505173488, Lingxiufeng_njfy@163.com
Xiufeng Ling
Argentina1 site
Biocódices
Buenos Aires
Jeremias Zubrzycki, jeremias.zubrzycki@biocodices.com
Jeremias Zubrzycki
Malaysia1 site
Thomson Hospital
Petaling Jaya
Ying Chen, yingchen.soo@tmclife.com
Ying Chen
Spain1 site
Institute Bernabéu
Alicante
Belén Lledó, blledo@institutobernabeu.com
Belén Lledó
About this study
Official title: Efficacy of PGT-A Upgrade in Preimplantation Genetic Testing of Embryos: An International Multicenter Prospective Clinical Study
The goals of this international multicenter cross-sectional study are:
- To provide patients with a comprehensive PGT solution capable of simultaneously detecting embryonic chromosomal aneuploidy, mosaicism, microdeletions/ microduplications, heteroploidy, and heterozygosity (LOH) in a single assay, thereby reducing miscarriage and birth defects;
- To perform PGT analysis on abnormally fertilized embryos, select euploid embryos with normal ploidy, and calculate embryo utilization rates;
- To reduce the false-positive rate through confirmation of mosaic embryos and subsequent analysis of its origin, thereby minimizing embryo wastage;
- To provide molecular genetic evidence for expert consensus on clinical management of atypically fertilized embryos, of pathogenic/likely pathogenic small CNVs, optimize mosaic embryo transfer strategies, and inform preconception intervention;
- To enhance international PGT testing standards through international multi-center collaboration.
The study will enroll patients undergoing PGT-A from seven domestic and international centers, with patient enrollment expected to be completed within one year. PGT-A upgrade testing will be performed on embryos from enrolled patients, and the incidence rates of Incidence of microdeletions/microduplications, heteroploidy, LOH will be statistically analyzed. All patients who undergo embryo transfer will be followed up for clinical outcomes and birth defects.
Read the detailed description
The study will enroll 6,694 embryos derived from typical fertilization (2PN) that meet the inclusion and exclusion criteria in patients undergoing PGT-A, as well as all embryos derived from atypical fertilization (0PN/1PN/3PN). In contrast to conventional PGT-A testing, PGT-A upgrade testing will be performed on the embryos to comprehensively analyze multiple embryonic abnormalities in a single detection, including aneuploidy, mosaicism, microdeletion/microduplication, heteroploidy, and loss of heterozygosity (LOH), and to calculate their respective incidence rates.
In addition to embryos derived from 2PN, embryos from 0PN/1PN/3PN will also be cultured to the blastocyst stage for trophectoderm (TE) cell biopsy. Euploid embryos identified by PGT-A upgrade testing will be recorded, and the utilization rate of atypically fertilized embryos will be evaluated.
For mosaic embryos, a previously established parental haplotype origin algorithm will be applied to distinguish true versus false mosaicism and identify the origin of abnormalities, thereby recognizing "false-positive" mosaic embryos and further increasing the number of transferable embryos.
Patients will receive euploid embryo transfer (from 2PN) in accordance with routine clinical practice. In cases where no 2PN-derived euploid embryos are available, transfer of 0PN/1PN/3PN-derived euploid embryos and embryos classified as "false-positive" mosaic may be considered after the patient has been fully informed of the risks and provided informed consent.
All transfer cycles will be followed up for prenatal diagnosis results and birth defects. The primary outcome measures are the incidence rates of microdeletion/microduplication, heteroploidy, and LOH. The secondary outcome measures include embryo utilization rate, clinical pregnancy rate, ongoing pregnancy rate, live birth rate, miscarriage rate, concordance rate between prenatal diagnosis results and PGT-A results, and birth defect rate.
The maximum follow-up duration will be 1 year after embryo transfer. Clinical and embryology laboratory procedures during the study will not be altered and will be performed in accordance with each center's routine practice.
- Being tested
- PGT-A upgrade
- Keywords
- Preimplantation Genetic Testing for Aneuploidies, Mosaic embryos, Microdeletions/microduplications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGT-A upgradeOther
A comprehensive PGT solution capable of simultaneously detecting embryonic chromosomal aneuploidy, mosaicism, microdeletions/ microduplications, heteroploidy, and LOH in a single assay.
| Study group | Role | What they receive |
|---|---|---|
| PGT-A upgrade group | Not described Receives: Other: PGT-A upgrade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of microdeletions/microduplications
Trophectoderm biopsy samples undergo whole genome amplification followed by NGS. Microdeletions and microduplications are identified according to Human Genome Assembly GRCh19 (hg19) or updated versions. The incidence will be calculated as the number of embryos with pathogenic or likely pathogenic microdeletions/microduplications (1-4M) divided by the total number of embryos.
Measured: Two months after oocyte retrieval
Incidence of heteroploidy
Trophectoderm biopsy samples undergo whole genome amplification followed by NGS. Heteroploidy is identified according to Human Genome Assembly GRCh19 (hg19) or updated versions. The incidence will be calculated as the number of embryos with heteroploidy divided by the total number of embryos.
Measured: Two months after oocyte retrieval
Incidence of loss of heterozygosity
Trophectoderm biopsy samples underwent whole genome amplification followed by NGS. Loss of heterozygosity were identified according to Human Genome Assembly GRCh19 (hg19) or updated versions. The incidence will be calculated as the number of embryos with loss of heterozygosity divided by the total number of embryos
Measured: Two months after oocyte retrieval
Secondary outcomes (7)
Transferable embryo rate
Trophectoderm biopsy samples undergo whole genome amplification followed by NGS. Normal karyotype is identified according to Human Genome Assembly GRCh19 (hg19) or updated versions. The rate will be calculated as the number of embryos with normal karyotype divided by the total number of embryos.
Measured: Two months after oocyte retrieval
Clinical pregnancy rate
Transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac
Measured: 28-30 days after embryo transfer
Ongoing pregnancy rate
Transvaginal ultrasonography will be performed. Ongoing pregnancy will be diagnosed with detection of an intrauterine gestational sac
Measured: 12 weeks after the embryo transfer
Live birth rate
Live birth rate is defined as delivery of any viable infant at 28 weeks or more of gestation, after embryo transfer
Measured: Two weeks after the newborn's birth
Early miscarriage rate
Number of pregnancy losses / number of clinical pregnancies after transfer
Measured: 12 weeks of after the embryo transfer
Concordance between prenatal diagnosis results and PGT-A results
Prenatal diagnosis result: Chromosomal analysis performed on fetal samples obtained through chorionic villus sampling or amniocentesis, including karyotyping, chromosomal microarray analysis or next-generation sequencing.
PGT-A result: Chromosomal analysis performed by PGT-A upgrade.
Measured: 16-24 weeks of gestation
Birth defect rate
Physical examination, echocardiography, X-ray/MRI, ophthalmologic examination, hearing screening
Measured: At 1 year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Infertility Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Yunnan, Nanjing Women and Children's Healthcare Hospital, Biocódices, Miracle, Institute Bernabéu, Thomson Hospital
- Responsible party
- Sponsor
- Investigators
- Ge Lin, Principal investigator, CITIC-Xiangya Reproductive & Genetic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533630
- Sponsor's protocol ID
- LL-SC-2026-003-01
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Considering regulatory requirements, the IPD will not be shared.
Publications
Capalbo A, Poli M, Rienzi L, Girardi L, Patassini C, Fabiani M, Cimadomo D, Benini F, Farcomeni A, Cuzzi J, Rubio C, Albani E, Sacchi L, Vaiarelli A, Figliuzzi M, Findikli N, Coban O, Boynukalin FK, Vogel I, Hoffmann E, Livi C, Levi-Setti PE, Ubaldi FM, Simon C. Mosaic human preimplantation embryos and their developmental potential in a prospective, non-selection clinical trial. Am J Hum Genet. 2021 Dec 2;108(12):2238-2247. doi: 10.1016/j.ajhg.2021.11.002. Epub 2021 Nov 18.
PubMed 34798051Capalbo A, Cimadomo D, Coticchio G, Ottolini CS. An expert opinion on rescuing atypically pronucleated human zygotes by molecular genetic fertilization checks in IVF. Hum Reprod. 2024 Sep 1;39(9):1869-1878. doi: 10.1093/humrep/deae157.
PubMed 39043217Zhang J, Mu F, Guo Z, Cai Z, Zeng X, Du L, Wang F. Chromosome analysis of foetal tissue from 1903 spontaneous abortion patients in 5 regions of China: a retrospective multicentre study. BMC Pregnancy Childbirth. 2023 Nov 25;23(1):818. doi: 10.1186/s12884-023-06108-0.
PubMed 38007414Fan Y, Li R, Huang J, Yu Y, Qiao J. Diploid, but not haploid, human embryonic stem cells can be derived from microsurgically repaired tripronuclear human zygotes. Cell Cycle. 2013 Jan 15;12(2):302-11. doi: 10.4161/cc.23103. Epub 2012 Jan 15.
PubMed 23255130Huan Q, Gao X, Wang Y, Shen Y, Ma W, Chen ZJ. Comparative evaluation of human embryonic stem cell lines derived from zygotes with normal and abnormal pronuclei. Dev Dyn. 2010 Feb;239(2):425-38. doi: 10.1002/dvdy.22175.
PubMed 19941346Canon C, Thurman A, Li A, Hernandez-Nieto C, Lee JA, Roth RM, Slifkin R, Briton-Jones C, Stein D, Copperman AB. Assessing the clinical viability of micro 3 pronuclei zygotes. J Assist Reprod Genet. 2023 Jul;40(7):1765-1772. doi: 10.1007/s10815-023-02830-y. Epub 2023 May 25.
PubMed 37227570Destouni A, Dimitriadou E, Masset H, Debrock S, Melotte C, Van Den Bogaert K, Zamani Esteki M, Ding J, Voet T, Denayer E, de Ravel T, Legius E, Meuleman C, Peeraer K, Vermeesch JR. Genome-wide haplotyping embryos developing from 0PN and 1PN zygotes increases transferrable embryos in PGT-M. Hum Reprod. 2018 Dec 1;33(12):2302-2311. doi: 10.1093/humrep/dey325.
PubMed 30383227Yao G, Xu J, Xin Z, Niu W, Shi S, Jin H, Song W, Wang E, Yang Q, Chen L, Sun Y. Developmental potential of clinically discarded human embryos and associated chromosomal analysis. Sci Rep. 2016 Apr 5;6:23995. doi: 10.1038/srep23995.
PubMed 27045374
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PGT-A Upgrade in Preimplantation Genetic Testing of Embryos: An International Multicenter Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07533630
- Acronym / sponsor ID
- LL-SC-2026-003-01
- Keywords
- Preimplantation Genetic Testing for Aneuploidies, Mosaic embryos, Microdeletions/microduplications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Collaborators
- The First People's Hospital of Yunnan, Nanjing Women and Children's Healthcare Hospital, Biocódices, Miracle, Institute Bernabéu, Thomson Hospital
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this international multicenter cross-sectional study are:
- To provide patients with a comprehensive PGT solution capable of simultaneously detecting embryonic chromosomal aneuploidy, mosaicism, microdeletions/ microduplications, heteroploidy, and heterozygosity (LOH) in a single assay, thereby reducing miscarriage and birth defects;
- To perform PGT analysis on abnormally fertilized embryos, select euploid embryos with normal ploidy, and calculate embryo utilization rates;
- To reduce the false-positive rate through confirmation of mosaic embryos and subsequent analysis of its origin, thereby minimizing embryo wastage;
- To provide molecular genetic evidence for expert consensus on clinical management of atypically fertilized embryos, of pathogenic/likely pathogenic small CNVs, optimize mosaic embryo transfer strategies, and inform preconception intervention;
- To enhance international PGT testing standards through international multi-center collaboration.
The study will enroll patients undergoing PGT-A from seven domestic and international centers, with patient enrollment expected to be completed within one year. PGT-A upgrade testing will be performed on embryos from enrolled patients, and the incidence rates of Incidence of microdeletions/microduplications, heteroploidy, LOH will be statistically analyzed. All patients who undergo embryo transfer will be followed up for clinical outcomes and birth defects.
Detailed description
The study will enroll 6,694 embryos derived from typical fertilization (2PN) that meet the inclusion and exclusion criteria in patients undergoing PGT-A, as well as all embryos derived from atypical fertilization (0PN/1PN/3PN). In contrast to conventional PGT-A testing, PGT-A upgrade testing will be performed on the embryos to comprehensively analyze multiple embryonic abnormalities in a single detection, including aneuploidy, mosaicism, microdeletion/microduplication, heteroploidy, and loss of heterozygosity (LOH), and to calculate their respective incidence rates.
In addition to embryos derived from 2PN, embryos from 0PN/1PN/3PN will also be cultured to the blastocyst stage for trophectoderm (TE) cell biopsy. Euploid embryos identified by PGT-A upgrade testing will be recorded, and the utilization rate of atypically fertilized embryos will be evaluated.
For mosaic embryos, a previously established parental haplotype origin algorithm will be applied to distinguish true versus false mosaicism and identify the origin of abnormalities, thereby recognizing "false-positive" mosaic embryos and further increasing the number of transferable embryos.
Patients will receive euploid embryo transfer (from 2PN) in accordance with routine clinical practice. In cases where no 2PN-derived euploid embryos are available, transfer of 0PN/1PN/3PN-derived euploid embryos and embryos classified as "false-positive" mosaic may be considered after the patient has been fully informed of the risks and provided informed consent.
All transfer cycles will be followed up for prenatal diagnosis results and birth defects. The primary outcome measures are the incidence rates of microdeletion/microduplication, heteroploidy, and LOH. The secondary outcome measures include embryo utilization rate, clinical pregnancy rate, ongoing pregnancy rate, live birth rate, miscarriage rate, concordance rate between prenatal diagnosis results and PGT-A results, and birth defect rate.
The maximum follow-up duration will be 1 year after embryo transfer. Clinical and embryology laboratory procedures during the study will not be altered and will be performed in accordance with each center's routine practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PGT-A upgrade group | – | Other: PGT-A upgrade |
Who may qualify
- Ages
- 20 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study is a cross-sectional study with a two-sided test and α = 0.05. Based on the analysis of existing data from previous PGT-A upgrade studies performed in 2PN embryos, the total incidence rate (p) of microdeletion/microduplication, heteroploidy, and UPD/LOH in euploid embryos is estimated to be 2.0%, with a margin of error (δ) of 0.005. The required number of euploid embryos is 3,012, and the calculation formula is provided below. Given that the euploidy rate is approximately 50%, a total of 6,024 embryos tested by PGT-A upgrade needs to be enrolled. Considering the potential dropout risk (10%), 6,694 embryos from two pronuclei (PN) are included. All embryos from 0PN/1PN/3PN are included.
Key inclusion criteria (5 listed)
- Any one of the following conditions being met is sufficient:
- advanced maternal age (AMA, age ≥35 years),
- recurrent implantation failure (RIF),
- recurrent miscarriage (RM),
- severe male factor (SMF). (2) And at least one blastocyst is available.
Key exclusion criteria (5 listed)
- Couples undergoing PGT-SR due to chromosomal structural abnormalities carried by either one or both members, such as balanced translocations, Robertsonian translocations, inversions, complex chromosomal rearrangements, and pathogenic microdeletions or microduplications;
- Couples undergoing PGT-M;
- Conditions with established impact on uterine morphology or endometrial receptivity, including untreated uterine malformations (septate uterus, unicornuate uterus, didelphic uterus, etc.) and untreated hydrosalpinx;
- Embryos coming from oocyte or sperm (gametes) donation;
- Individuals with contraindications to pregnancy or assisted reproduction technology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PGT-A upgradeA comprehensive PGT solution capable of simultaneously detecting embryonic chromosomal aneuploidy, mosaicism, microdeletions/ microduplications, heteroploidy, and LOH in a single assay. | Other | PGT-A upgrade group |
Primary outcome
Incidence of microdeletions/microduplications
Time frame: Two months after oocyte retrieval
Trophectoderm biopsy samples undergo whole genome amplification followed by NGS. Microdeletions and microduplications are identified according to Human Genome Assembly GRCh19 (hg19) or updated versions. The incidence will be calculated as the number of embryos with pathogenic or likely pathogenic microdeletions/microduplications (1-4M) divided by the total number of embryos.
Incidence of heteroploidy
Time frame: Two months after oocyte retrieval
Trophectoderm biopsy samples undergo whole genome amplification followed by NGS. Heteroploidy is identified according to Human Genome Assembly GRCh19 (hg19) or updated versions. The incidence will be calculated as the number of embryos with heteroploidy divided by the total number of embryos.
Incidence of loss of heterozygosity
Time frame: Two months after oocyte retrieval
Trophectoderm biopsy samples underwent whole genome amplification followed by NGS. Loss of heterozygosity were identified according to Human Genome Assembly GRCh19 (hg19) or updated versions. The incidence will be calculated as the number of embryos with loss of heterozygosity divided by the total number of embryos
7 secondary outcomes
Transferable embryo rate
Time frame: Two months after oocyte retrieval
Clinical pregnancy rate
Time frame: 28-30 days after embryo transfer
Ongoing pregnancy rate
Time frame: 12 weeks after the embryo transfer
Live birth rate
Time frame: Two weeks after the newborn's birth
Early miscarriage rate
Time frame: 12 weeks of after the embryo transfer
Concordance between prenatal diagnosis results and PGT-A results
Time frame: 16-24 weeks of gestation
Birth defect rate
Time frame: At 1 year postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 34798051Capalbo A, Poli M, Rienzi L, Girardi L, Patassini C, Fabiani M, Cimadomo D, Benini F, Farcomeni A, Cuzzi J, Rubio C, Albani E, Sacchi L, Vaiarelli A, Figliuzzi M, Findikli N, Coban O, Boynukalin FK, Vogel I, Hoffmann E, Livi C, Levi-Setti PE, Ubaldi FM, Simon C. Mosaic human preimplantation embryos and their developmental potential in a prospective, non-selection clinical trial. Am J Hum Genet. 2021 Dec 2;108(12):2238-2247. doi: 10.1016/j.ajhg.2021.11.002. Epub 2021 Nov 18.
- Background: PubMed 39043217Capalbo A, Cimadomo D, Coticchio G, Ottolini CS. An expert opinion on rescuing atypically pronucleated human zygotes by molecular genetic fertilization checks in IVF. Hum Reprod. 2024 Sep 1;39(9):1869-1878. doi: 10.1093/humrep/deae157.
- Background: PubMed 38007414Zhang J, Mu F, Guo Z, Cai Z, Zeng X, Du L, Wang F. Chromosome analysis of foetal tissue from 1903 spontaneous abortion patients in 5 regions of China: a retrospective multicentre study. BMC Pregnancy Childbirth. 2023 Nov 25;23(1):818. doi: 10.1186/s12884-023-06108-0.
- Background: PubMed 23255130Fan Y, Li R, Huang J, Yu Y, Qiao J. Diploid, but not haploid, human embryonic stem cells can be derived from microsurgically repaired tripronuclear human zygotes. Cell Cycle. 2013 Jan 15;12(2):302-11. doi: 10.4161/cc.23103. Epub 2012 Jan 15.
- Background: PubMed 19941346Huan Q, Gao X, Wang Y, Shen Y, Ma W, Chen ZJ. Comparative evaluation of human embryonic stem cell lines derived from zygotes with normal and abnormal pronuclei. Dev Dyn. 2010 Feb;239(2):425-38. doi: 10.1002/dvdy.22175.
- Background: PubMed 37227570Canon C, Thurman A, Li A, Hernandez-Nieto C, Lee JA, Roth RM, Slifkin R, Briton-Jones C, Stein D, Copperman AB. Assessing the clinical viability of micro 3 pronuclei zygotes. J Assist Reprod Genet. 2023 Jul;40(7):1765-1772. doi: 10.1007/s10815-023-02830-y. Epub 2023 May 25.
- Background: PubMed 30383227Destouni A, Dimitriadou E, Masset H, Debrock S, Melotte C, Van Den Bogaert K, Zamani Esteki M, Ding J, Voet T, Denayer E, de Ravel T, Legius E, Meuleman C, Peeraer K, Vermeesch JR. Genome-wide haplotyping embryos developing from 0PN and 1PN zygotes increases transferrable embryos in PGT-M. Hum Reprod. 2018 Dec 1;33(12):2302-2311. doi: 10.1093/humrep/dey325.
- Background: PubMed 27045374Yao G, Xu J, Xin Z, Niu W, Shi S, Jin H, Song W, Wang E, Yang Q, Chen L, Sun Y. Developmental potential of clinically discarded human embryos and associated chromosomal analysis. Sci Rep. 2016 Apr 5;6:23995. doi: 10.1038/srep23995.
- Individual participant dataSharing planned: No. Considering regulatory requirements, the IPD will not be shared.
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Infertility Assisted Reproductive Technology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ge Lin principal investigator
CITIC-Xiangya Reproductive & Genetic Hospital
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility Assisted Reproductive Technology, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, Argentina, Malaysia, South Korea, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pingyuan Xie (8613755122491, plainxie192@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of microdeletions/microduplications (time frame: Two months after oocyte retrieval). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07533630, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.